PerkinElmer's new Spectrum v4.0 CFR software is designed to meet the needs of highly regulated laboratories and to meet the requirements of the US FDA
PerkinElmer's new Spectrum v4.0 CFR software has been developed for use with its Spectrum One and Spectrum One NTS FT-IR systems.
It is designed to meet the needs of highly regulated laboratories, such as those found in the pharmaceutical and healthcare industries.
All pharmaceutical companies marketing, or intending to market, their products into the USA are now subject to FDA 21 CFR-11 regulations relating to the integrity of electronic data records.
Companies are responsible for procedural compliance, while for technical compliance, testing instrumentation must itself be capable of compliance with 21 CFR-11.
Spectrum v4.0 CFR combines with Spectrum One and Spectrum One NTS systems to ensure technical compliance in the two required areas: software development and data integrity.
The software has been developed, tested and validated in compliance with the requirements of 21 CFR-11.
Data integrity compliance is provided by secure log-in, multi-level user access groups for users with different permission levels, and audit trails, recording all changes to users, groups and password settings, as required by the FDA.
